Dirty syringes: FDA failed to shut down troubled plant, and family paid price

Christina Jewett ProPublica

Natalie Fullerton's parents were thrilled to watch their year-old daughter bounce back from a double-lung transplant. Within months, she was mimicking her sister's ballet poses and gleefully repeating the word "purple."

Her father, Leslie, carefully tended to Natalie, following an intricate regimen to keep her healthy. After doctors implanted a tube in Natalie's chest to give her intravenous medication, he dutifully used fluid-filled syringes to clean it.

Days later, the 29-month-old was back in a Texas hospital, breathless and feverish. Bacteria had infected her blood, the first in a cascade of complications over four months. In the end, Natalie died in her mother's arms on March 12, 2008.

Leslie Fullerton can't shed his sense of guilt. "I'm the one who killed my daughter," he said.

But a large body of evidence points elsewhere.

Natalie's father had used syringes from a contaminated lot made in a factory owned by a Lake Zurich businessman. That batch and another have since been linked to four deaths and 162 illnesses nationwide, including 22 in Illinois.

Moreover, an examination of inspection reports and other documents shows that the U.S. Food and Drug Administration missed several chances to stop the tainted syringes from being used by patients.

Three months before the prefilled syringes were shipped in October 2007, an FDA inspector visited the plant in North Carolina where they were made. She investigated reports of red, brown and black particles in syringes and reported that managers had a plan to deal with rust.

The inspector did not note that the plant had switched to an unreliable sterilization method.

A week later, when the FDA learned a distributor was recalling 1.3 million of the syringes, the agency should have launched a thorough inspection, according to its operations manual. That didn't happen, an FDA spokeswoman now says, because the agency is so understaffed it no longer follows the policy unless the recalled product poses a reasonable probability of serious injuries or deaths.

Finally, after receiving reports of harm in late 2007, FDA inspectors combed the plant, called AM2PAT. They discovered a "gummy brown" substance on the syringe-filling machine and brown water flowing from taps, among other problems. The plant was closed in January 2008.

Federal prosecutors zeroed in on AM2PAT President Dushyant Patel, who lived in Chicago's northwest suburbs but commuted to operate AM2PAT. An indictment on fraud, conspiracy and other charges alleges that his firm lied about performing sterility tests and produced prefilled syringes laced with bacteria.

Patel fled the country as investigators closed in, evading charges that could bring 95 years in prison, prosecutors say. Two employees, including a Carpentersville man who was the plant manager, were sentenced in February to 4 1/2 years in prison for fraud and for allowing tainted drugs into the marketplace.

The syringe case has not received the attention that followed deaths this year from salmonella-laden peanut paste, another instance in which the FDA was criticized for acting slowly. Consumer advocates and experts who follow the FDA say both safety breakdowns are the predictable result of a long-term shift from aggressive enforcement to "partnership" with the industries it oversees.

"That tells me if the cop leaves the beat, the bad guys feel that they can do what they want to do," said William Hubbard, a former FDA associate commissioner and consultant to the advocacy group Alliance for a Stronger FDA.

For this article, Gordon Harnack, a consultant who helps medical device companies prepare for inspections, reviewed more than 120 pages of FDA reports on the AM2PAT plant dating to 2005. He said inspectors didn't look deep enough, even as contamination problems at the plant became apparent.

"Time after time, the evidence was there that [AM2PAT] management had little intent of complying with adequate FDA regulations," Harnack said.

Responding to the way the agency investigated the plant and inquiries for this story, newly sworn FDA Commissioner Margaret Hamburg on Saturday pledged to make product safety a "top priority."

"This incident underscores my belief that it is critically important for the FDA to take an aggressive approach to inspections and maintain vigilance in ensuring that manufacturers fully comply with their regulatory, legal and moral obligations to ensure that the products they produce for the American people are safe and effective," Hamburg said in a statement.

Earlier, FDA spokeswoman Siobhan DeLancey had defended the agency's actions, saying inspectors visited the AM2PAT plant multiple times over several years on a "relatively low number of complaints." Once reports of infections came in, the agency worked hard to help prosecute the two plant managers, she said.

But that was too late for the Fullertons and other families who link the syringes to death or illness. Many have filed lawsuits in Cook County against AM2PAT; in their case, the Fullertons claim that an AM2PAT syringe compromised Natalie's health and led to her death.

Jim Tallian of northwest suburban Palatine blames AM2PAT for an infection that set back his recovery from a bone marrow and blood illness that often leads to leukemia.

Tallian, then living in Crystal Lake, had received a stem cell transplant when an AM2PAT syringe was used to flush a catheter in his chest on Dec. 3, 2007, according to his lawsuit. He contracted a bloodstream infection and was treated at Rush University Medical Center for four days.

"I was shaking so bad it was like I was having convulsions," he said. "I couldn't stop."

Unaware his syringes might be contaminated, he had his catheter flushed again the day after he was discharged. Tallian fell ill a second time and had to be rushed to the emergency room.

"I was in a very vulnerable situation because I had just gotten out of the hospital after my transplant," said Tallian, who is married and has three children. "After three weeks of chemotherapy, anything could take you out."

Buying into the business

Dushyant Patel, a former pharmacist, bought a share of the North Carolina business in 2001 and took over as president. He lived with his wife and two children on a cul-de-sac in Lake Zurich, where neighbors described him as friendly but constantly working and regularly out of town.

Prosecutors allege Patel's operation was a fraud from the start, saying the firm's application to make syringes included fake data for a test to establish their shelf life. Apparently unaware, the FDA gave Patel the go-ahead to start production in late 2003.

The firm bought empty syringes and filled them with saline or the blood thinner heparin, solutions that prevent clots from forming in catheters used to deliver medicine directly into a vein.

AM2PAT sold its syringes to distributors that marketed them to hospitals and pharmacies. The factory earned nearly $7 million in profits during its final two years, according to prosecutors.

The federal indictment accuses Patel of doctoring records at the factory and putting "adulterated" drugs into the marketplace. Authorities believe he is in his native India and are seeking to extradite him.

The plant, located in a former strip mall in Raleigh, initially didn't attract much FDA scrutiny. Then, in March 2005, a pharmacist reported finding "copious" amounts of orange sediment floating in an AM2PAT syringe, FDA records show. He saw an inch-long black hair suspended in another.

An FDA inspector arrived at the plant in June 2005 and spent six days there, much of it at Patel's side. She watched a worker fill a syringe while chewing gum and saw others inspecting syringes at a conveyor that was moving too fast.

She noted nine "significant" violations, records show, some of which could have "an adverse effect on product quality."

Soon after, the FDA sent a warning letter requiring AM2PAT to correct the problems. After another visit in January 2006, the FDA said Patel had either fixed or promised to address the major concerns.

In the spring and summer of 2007, a patient's relative and medical workers lodged new complaints with the FDA. "White wispy" material floated in one syringe, according to the FDA complaint. A patient with a bloodstream infection saw brown particles in another syringe from the same batch. An AM2PAT worker claimed management "was not adhering to the appropriate clean-room temperature during manufacturing."

The FDA's Atlanta branch scheduled an inspection for June 26, 2007, but when the inspector arrived in Raleigh, the plant was shuttered.

By the time an inspector tracked AM2PAT to a new site, 30 miles south in Angier, one of the plant's distributors had taken action based on other complaints.

B. Braun Medical of Bethlehem, Pa., told customers on July 30 that it was recalling more than 1 million syringes following reports of particles floating in the saline. FDA policies do not set a deadline for companies to report a recall, and the agency didn't learn of B. Braun's action until a week later, spokeswoman DeLancey said.

Unaware of the recall, the inspector focused on other reports of particles in the syringes. She walked through the plant and reported that managers had a plan to deal with rust contamination.

Harnack, the industry consultant, said the inspector should have delved deeper, knowing the company violated FDA regulations by not reporting its move to Angier. She should have made sure AM2PAT re-evaluated its equipment and, given a report of contamination, pulled samples for testing, he said. Six weeks after the August inspection, the FDA issued a news release on the B. Braun recall. The particles were medical-grade silicone, the agency said, and were capable of causing brain damage or a deadly clot.

The FDA now acknowledges that until reports of contamination-related injuries mounted, its Philadelphia office did not pass along information about the recall to its Atlanta branch. That office managed AM2PAT inspections and knew the plant's history. "It was a lapse in communication," DeLancey said.

Tainted syringes shipped

Toward the end of October 2007, the plant shipped heparin-filled syringes contaminated with bacteria, authorities say, and patients who used them soon started arriving at hospitals from Florida to Nebraska.

Health authorities now link four deaths to the contamination. But because of patient privacy laws, it is unclear whether they include Natalie in that tally. The family's lawsuit is still pending.

After the Centers for Disease Control and Prevention linked sick patients to the syringes on Dec. 11, 2007, two FDA investigators and a microbiologist arrived at the factory. Over two weeks, they interviewed workers, dug through records, examined equipment and studied quality control.

Inspectors learned Patel had concluded—for reasons the company was unable to document—that the white particles that spurred the recall were caused by a failure of a standard sterilization process involving radiation. Patel then adopted "UV light" sterilization, which the FDA called a "novel, non-traditional" technique.

An employee also told investigators that for six months workers at the plant had been rushing syringes out the door before completing sterility tests.

To cover up the practice, the criminal indictment alleges, the company kept two sets of records—one revealing the rushed shipments and another stating falsely that the plant was holding syringes on-site for 14 days while chemists conducted sterility tests.

When confronted with the duplicate paperwork, Patel said someone was "sabotaging" his records, according to the FDA's account.

Back in the Chicago area, Patel's wife and children apparently still live in their suburban home, but she did not respond to requests for comment. In a brief interview, his younger brother said he last heard from Patel 1 1/2 years ago and was worried about him.

"He's the nicest person, the most brilliant mind," said Mehul Patel, who lives in Texas. "I don't know when something went wrong."

Deborah L. Shelton is a Tribune reporter. Christina Jewett is a reporter for ProPublica, an independent, non-profit investigative newsroom in New York. Funded primarily by the Sandler Foundation, ProPublica publishes its work at propublica.org and through partnerships with the Tribune and other media. dshelton@tribune.com